(425 days)
The FaceMaster Facial Toning System ("FaceMaster System") is intended to stimulate the face. The device is indicated for cosmetic use.
The FaceMaster System is a transcutaneous electrical stimulator that incorporates a control module and two electrodes on separate, handheld probes to deliver electrical stimulation to the face muscles. The device is prepared for use by laying it flat on a table, opening the control module cover and removing the probes from their cradles inside the control module. Conductive solution is dispensed into a basin within the control module and, after placing the foam pads over the distal end of each probe the pads are soaked in the solution until they are moist. The user then pushes the power (ON/OFF) button to turn the device on and follows the instructions for use and the LCD and audible prompts from the control module to complete the three cosmetic stimulation modes, i.e., the eye cycle, the facial cycle, and the feathering cycle.
The provided text describes the 510(k) summary for the FaceMaster® Facial Toning System (K040871). Here's an analysis to extract the requested information:
Acceptance Criteria and Study Details for FaceMaster® Facial Toning System (K040871)
1. Table of Acceptance Criteria and Reported Device Performance
The submission for K040871 is primarily a substantial equivalence claim based on predicate devices and a clinical study that included "trained observers and self-assessments." It explicitly states that the device "complies with FDA's performance standard for electrode lead wires and patient cables set forth in 21 C.F.R. § 898.12."
However, no specific quantitative acceptance criteria or a reported performance matrix (e.g., sensitivity, specificity, accuracy, or a specific metric for "toning") are provided in the document. The study's purpose was to "demonstrate the substantial equivalence... for OTC cosmetic use," implying the performance was considered "substantially equivalent" to the predicate, rather than meeting predefined quantitative metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria are provided in the document for the cosmetic effects of facial toning. | The clinical study, including trained observers and self-assessments, supported the device's substantial equivalence to predicate devices for OTC cosmetic use. |
| Compliance with FDA performance standard for electrode lead wires and patient cables (21 C.F.R. § 898.12). | The device complies with 21 C.F.R. § 898.12. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A clinical study of the FaceMaster System," but does not specify the sample size for this study or whether it had a distinct "test set." It also does not mention the country of origin of the data nor if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study "included testing both with trained observers and self-assessments."
- Number of Experts: Not specified.
- Qualifications of Experts: The term "trained observers" is used, but no specific qualifications (e.g., dermatologists, cosmetologists, level of experience) are provided.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the "trained observers" or self-assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The FaceMaster System is a direct-to-consumer electrical stimulation device, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The FaceMaster System is a physical device used directly by a human, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the clinical study appears to be a combination of:
- Trained Observer Assessments: Subjective evaluations by individuals trained for the purpose of the study.
- Self-Assessments: Subjective evaluations provided by the users themselves.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The clinical study mentioned appears to be the primary study for evaluation, not a split into training and test sets in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" is not mentioned, the method for establishing its ground truth is not applicable.
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K040871
JUN 1 - 2005
510(k) SUMMARY
FaceMaster of Beverly Hills, Inc. FaceMaster® Facial Toning System
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
FaceMaster of Beverly Hills, Inc. 23679 Calabasas Road, PMB 665 Calabasas, California 91302-1501
Telephone: (818) 222-2461 Facsimile: (818) 222-6534 E-Mail: J.Engco@Worldnet.Att.Net Contact Person: Mr. Jim England
Date Prepared: April 1, 2004
Name of Device and Name/Address of Sponsor
FaceMaster Facial Toning System
FaceMaster of Beverly Hills, Inc. 23679 Calabasas Road, PMB 665 Calabasas, CA 91302-1501
Common or Usual Name
FaceMaster Facial Toning System
Classification Name
Transcutaneous Electrical Nerve Stimulator (21 C.F.R. § 882,5890)
Predicate Devices
Salton, Inc.'s Rejuvenique® Facial Toning System, Model RJV-10
Intended Use / Indications for Use
The FaceMaster Facial Toning System ("FaceMaster System") is intended to stimulate the face. The device is indicated for cosmetic use.
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The FaceMaster System is a transcutaneous electrical stimulator that incorporates a control module and two electrodes on separate, handheld probes to deliver electrical stimulation to the face muscles. The device is prepared for use by laying it flat on a table, opening the control module cover and removing the probes from their cradles inside the control module. Conductive solution is dispensed into a basin within the control module and, after placing the foam pads over the distal end of each probe the pads are soaked in the solution until they are moist. The user then pushes the power (ON/OFF) button to turn the device on and follows the instructions for use and the LCD and audible prompts from the control module to complete the three cosmetic stimulation modes, i.e., the eye cycle, the facial cycle, and the feathering cycle.
Performance Data
The FaceMaster Facial Toning System complies with FDA's performance standard for electrode lead wires and patient cables set forth in 21 C.F.R. § 898.12. A clinical study of the FaceMaster System, which included testing both with trained observers and self-assessments, was completed to demonstrate the substantial equivalence of the FaceMaster System to other transcutaneous electrical nerve stimulator devices for OTC cosmetic use.
Substantial Equivalence
The FaceMaster System is substantially equivalent to other legally marketed transcutaneous electrical nerve stimulator devices for cosmetic use. Specifically, the FaceMaster System is substantially equivalent to Salton, Inc.'s Rejuvenique® Facial Toning System ("Rejuvenique" or the "predicate device"). The FaceMaster System has the same intended use and the same indication for use as the Rejuvenique. The device also has similar technological characteristics as its predicate device. Minor differences in the technological characteristics of the FaceMaster System and the Rejuvenique do not raise any new issues of safety or effectiveness. Thus, the FaceMaster System is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
JUN 1 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FaceMaster of Beverly Hills, Inc. c/o C. Stephen Lawrence Hogan & Hartson, L.L.P. 2603 Main Street, Suite 1170 Irvine, California 92614
Re: K040871
Trade/Device Name: FaceMaster Facial Toning System Regulation Number: 21 CFR 882.5850 Regulation Name: Transcutaneous Electrical Stimulator for Cosmetic Use Regulatory Class: Class II Product Code: NFO Dated: March 1, 2005 Received: March 3, 2005
Dear Mr. Lawrence:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. C. Stephen Lawrence
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailies of substantial equivalence of your device to a legally premarket notincation. The President of eaching of evice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acries ion 7542 240) 276-0120. Also, please note the regulation entitled, Connact the Office of Complains on (xet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octoss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Styet Klude
Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
FaceMaster® Facial Toning System
Indications for Use:
The FaceMaster® Facial Toning System is intended to stimulate the face. The device is indicated for cosmetic use.
Prescription Use _ (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use_X_
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styet Clurdu
(Division Si on-Off Division of General, Restorative, and Neurological Devices
510(k) Number K040871
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§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).